cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard of care.

• Subjects who are willing and able to provide informed consent.

• Subjects who are willing and able to participate in all testing associated with this clinical study at an approved clinical investigational center.

• Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Locations
Other Locations
China
Beijing Anzhen Hospital of the Capital University of Medical Sciences
RECRUITING
Beijing
Huaxi Hospital of Sichuan University
RECRUITING
Chengdu
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Hong Kong
Queen Mary Hospital
RECRUITING
Hong Kong
Japan
Yokosuka Kyosai Hospital
RECRUITING
Kanagawa
Osaka Keisatsu Hospital
RECRUITING
Osaka
Malaysia
Institute Jantung Negara
RECRUITING
Kuala Lumpur
Singapore
Asian Heart and Vascular Centre
RECRUITING
Singapore
Taiwan
Taichung Veterans General Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Jamie Kwek
Jamie.Kwek@bsci.com
+6564188833
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 433
Treatments
Treatment Subjects
A subject is considered enrolled once an approved informed consent form has been signed and dated. Enrolled Subjects will undergo AF ablation procedure with the FARAPULSE PFA System, followed by WATCHMAN implant during the same procedure.
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov